electricparadise

FLU VACCINE
Oh, Canada?

For years, the Bush administration – at the behest of the pharmaceutical industry – has been blocking access to cheaper FDA-approved prescription drugs imported from Canada because it claimed they were not safe. But yesterday, in an abrupt about face, the administration announced the FDA is in "active negotiations" to obtain an extra 1.5 million doses of flu vaccine from a Canadian manufacturer. Acting FDA Commissioner Lester Crawford said "the FDA would inspect the Canadian facilities to see if they meet U.S. standards" and, if they meet those standards, it is possible the Canadian-made vaccine "would make it to American consumers this flu season." The FDA did not explain why, if the safety of Canadian-made vaccine could be established so quickly, it still hasn't figured out whether prescription drugs reimported from Canada are safe. (For the record, the FDA "can't name a single American who's been injured" from drugs purchased from a Canadian pharmacy.)

CANADIANS CONTRADICT CRAWFORD'S CLAIM: Crawford tried to save face by telling American reporters that "purchases of foreign vaccine would likely be done on a government-to-government basis, with U.S. authorities taking direct possession of the additional supplies," but Canadian officials said that's not true. "Certainly not that I'm aware of," said Dr. David Butler-Jones, head of Canada's new Public Health Agency. "Given that the vaccine that is available is either in the private sector or already in the provinces' and territories' hands, largely, that would be kind of funny to buy that back. "

THE ADMINISTRATION WAS WARNED: The president continues to blame "a production flaw" for the vaccine shortage, but the Bush administration received warnings about the vaccination supply and could have taken steps to diminish the problem. After Chiron Corp. informed British and American officials on Sept. 13 that there were unresolved contamination problems at its Liverpool, England, plant, the British government responded by contacting other manufacturers and securing alternative supplies. The Bush administration, on the other hand, failed to act before all doses of the flu vaccine had been purchased. The administration had already ignored two GAO reports which warned of #13; http://aging.senate.gov/events/hr67gao.pdf" href="http://aging.senate.gov/events/hr67gao.pdf">.

TOO LITTLE, TOO LATE? The secretary of Health and Human Services also announced yesterday that 2.6 million extra doses of the flu vaccine would be made available through Aventis Pasteur, the one company still approved by the FDA to sell flu vaccines this year. Even with these added doses, 40 percent of Americans who want the vaccine will have to go without the shot. And the new shipment also will arrive well "after the date the government recommends for vulnerable Americans to have had their shots," making it "unclear how helpful the extra vaccine doses will be." The new doses will not be available until January; the Centers for Disease Control and Prevention recommend that people be vaccinated in October or November.

HEALTH IS A CONGRESSIONAL PERK: There's one place in the United States. that isn't experiencing a flu vaccine shortage: Congress. "Directly contraven[ing] the instruction being given by the government's executive branch," Senate Majority Leader Bill Frist (R-TN) and the Capitol's attending physician are urging "all 535 lawmakers to get the vaccines even if they are young and healthy." Despite the shortage, many lawmakers were quick to comply, making sure to get their flu shots before they headed home to campaign this month. Those who haven't gotten their shots plan to, like Sen. Joseph I. Lieberman (D-CT), who said in an interview yesterday: "I haven't done it yet, but I want to." All told, the congressional physician's office "has dispensed nearly 2,000 flu shots this fall, and doses remained available yesterday." E-mail your members of Congress to see whether they're bypassing the lines to get shots for themselves.

FLU SHORTAGE COULD AFFECT TROOP READINESS: AP reports, "At military bases already strained by the demands of war in Iraq and Afghanistan, the men and women who defend the nation aren't being defended against the flu." Normally, "the Navy hospital at Camp Lejeune…would be getting 50,000 to 60,000 doses of flu vaccine." This year, however, the base has yet to receive a single dose. This is especially dangerous in a time of war: special operations Marines can be deployed at any time but will be vaccinated only after the Department of Defense decides how to dole out the military's supply. "If they get exposed to an area where the flu is epidemic, there is a readiness problem," said George Reynolds, director of community health at Lejeune's hospital.

HOMELAND SECURITY
Funding Up in Flames

A new Homeland Security appropriations bill signed by President Bush on Monday cuts funding for first responders by nearly $500 million and shortchanges programs vital to local fire departments. This didn't stop President Bush from appearing in New Jersey to assure voters the new law included "vital money for first responders." In fact, the president had provided inadequate funding for first responders even before the latest cut. Last year, the Council on Foreign Relations reported America would fall $98.4 billion short of meeting critical emergency responder needs over the next five years if current funding levels were maintained.

BUSH HOSES FIREFIGHTERS: The president's homeland security cuts could hit firefighters – whom Bush has called part of America's "new generation of heroes" – especially hard. The new bill cuts state homeland security block grants by 35 percent, and halves funding for Urban Search and Rescue grants. FIRE Act Grants – used to purchase fire equipment for local departments – have been cut for the first time since 9/11. These programs would have been cut further, says Fire Fighters Union President Harold Schaitberger, if Congress had followed the president's initial budget proposals, which "zeroed out funding for the FIRE Act program" and fought against an act meant to add firefighters to the nearly two-thirds of America's fire departments that are understaffed. Schaitberger called Bush's disingenuous claims of increases in homeland security "deplorable."

PROBLEM: BUSH WON'T REQUIRE INDUSTRY TO SECURE CRITICAL INFRASTRUCTURE: The private sector controls "85 percent of the nation's critical infrastructure." The 9/11 Commission report says, "homeland security and national preparedness...often begins with the private sector." Nevertheless, the Bush administration refuses to require private companies to secure chemical plants, nuclear reactors, seaports, water systems or the transportation of hazardous materials from a potentially catastrophic terrorist attack. For example, an attack at one or more of the nation's 15,000 industrial chemical plants across the United States "could cause thousands, even millions of deaths or injuries. A 2001 Army study found "2.4 million people could be killed or wounded by a terrorist attack on a single [chemical] plant."

EXPLANATION: CRITICAL INFRASTRUCTURE INDUSTRY LINES BUSH'S POCKETS: A new report from Public Citizen reveals that private companies which control the nation's critical infrastructure are among President Bush's "biggest campaign contributors." Ten Bush Rangers (those who raised $200,000+ for Bush's re-election campaign) and 20 Bush Pioneers ($100,000+) are executives from these industries. The companies themselves have "spent at least $201 million lobbying the White House, executive branch agencies and Congress from 2002 through June 2004." Public Citizen notes these companies "do not want new rules to follow even if their participation could help to stave off a terrorist attack."

HOLES IN THE BIOSHIELD: President Bush has touted his support for Project BioShield, the federal program designed to combat potential biowarfare. In his speech Tuesday, he said, "Through Project BioShield, we are developing new vaccines and treatments against biological attacks." But while Bush claimed last July that he would make $5.6 billion available to Project BioShield to counter anticipated threats, so far "no money from BioShield has been allocated." Instead, experts claim, the law has generated "indifference or frustration among biodefense contractors." According to a new study by the Center for Biosecurity, experts believe the U.S. is "woefully ill-equipped" to handle a sophisticated biological attack by terrorists.

TSA'S PATTERN OF WASTE: A recent Department of Homeland Security audit found the Transportation Security Administration, the government agency in charge of airport security, was guilty of lax oversight and unsound practices in awarding government contracts. According to the report, the TSA ended up overpaying Boeing Co. by at least $49 million for "the installation and maintenance of explosives detection equipment at U.S. airports." The report concluded TSA "didn't use 'sound contracting practices' in awarding the contract to Boeing; also, the agency failed to monitor progress and never conducted evaluations to ensure the work was being completed. This is just the latest example of fiscal irresponsibility to plague the two-year-old agency; TSA recently was under fire after reports surfaced that the agency awarded bonuses three times larger than the government average to its executives and spent a half million dollars on an extravagant party for staff members.


Under the Radar

Neon Beach

More? Know what? You can't possibly blame every little oversight or mistake on the leader of a country. There are others who have been designated or hired to look after all the little things that the head honcho gets blamed for. Not all of them were appointed by Bush, they've been there for years. I used to work with a guy like you, used to walk around with newspaper clippings of political articles in every pocket and keep daily notes about them. He's a lonely alcoholic now and sits at home brewing over things that, in the long run, mean nothing.

sizzlestan

Neon

It's gotta be Bush's fault. He is the reason why everything wrong in the Universe happens. If some pharmacy doesnt have proper quality controls and all of their flu vaccines are contaminated then IT HAS TO BE BUSH'S FAULT because doesnt he run the FDA? Oh yeah, he does not! So quit your tramping. The US has found over 2 mil new vaccines from France. Imagine the French helping the Bush administration save face because of the Kerry attacks made while he speaks to seniors. This is the dirtiest campaign I have even seen, EVER! While Bush has said some wild things Kerry goes over the top if there is such a thing.

KERRY WILL SAY ANYTHING TO ANYBODY TO GET THEIR VOTE - PERIOD! He speaks to seniors and he talks about Bush didnt get you your flu shot and Bush is going to stop your Social Security checks. Guess what? Bush cant do either. He doesnt control Social Security and he doesnt run the FDA. If you think for a second that Kerry can promise all he has promised and delivery all that he has promised then sell all your things today because come Jan 1st you will owe IT ALL to the Kerry government for the programs he has promised in his various campaign stops. What a big F*c*i*g joke he is. And electric is voting for him.

Ezliving_Jim

La Grippe of the Trial Lawyers

Guess who's to blame for the flu vaccine fiasco.

JOHN KERRY wasted no time jumping on President George Bush about the unexpected shortage in flu vaccines this year. Why wasn't Bush paying attention? He should have done things differently. And of course Kerry had a "plan" to solve the whole mess.

If Kerry thinks he can solve the flu vaccine problem, he need look no further than his own running mate, trial lawyer John Edwards. Vaccines are the one area of medicine where trial lawyers are almost completely responsible for the problem. No one can plausibly point a finger at insurance companies, drug companies, or doctors. Lawyers have won the vaccine game so completely that nobody wants to play.

Two weeks ago, British regulators suspended the license of Chiron Corp., the world's second-leading flu vaccine supplier, for three months. Officials cited manufacturing problems at the factory in Liverpool, England, where Chiron makes its leading product, Fluvirin. Chiron was scheduled to supply 46 million of the 100 million doses to be administered in the United States this year. The other 54 million will come from Aventis Pasteur, a French company with headquarters in Strasbourg.

So why is it that 100 percent of our flu vaccines are now made by two companies in Europe? The answer is simple. Trial lawyers drove the American manufacturers out of the business.

In 1967 there were 26 companies making vaccines in the United States. Today there are only four that make any type of vaccine and none making flu vaccine. Wyeth was the last to fall, dropping flu shots after 2002. For recently emerging illnesses such as Lyme disease, there is no commercial vaccine, even though one has been approved by the Food and Drug Administration.

All this is the result of a legal concept called "liability without fault" that emerged from the hothouse atmosphere of the law schools in the 1960s and became the law of the land. Under the old "negligence" regime, you had to prove a product manufacturer had done something wrong in order to hold it liable for damages. Under liability without fault, on the other hand, the manufacturer can be held responsible for harm from its products, whether blameworthy or not. Add to that the jackpot awards that come from pain-and-suffering and punitive damages, and you have a legal climate that no manufacturer wants to risk.

In theory, prices might have been jacked up enough to make vaccine production profitable even with the lawsuit risk, but federal intervention made vaccines a low-margin business. Before 1993, manufacturers sold vaccines to doctors, doctors prescribed them to patients, and there was some markup. Then Congress adopted the Vaccine for Children Act, which made the government a monopsony buyer. The feds now purchase over half of all vaccines at a low fixed price and distribute them to doctors. This has essentially finished off the private market.

As recently as 1980, 18 American companies made eight different vaccines for various childhood diseases. Today, four companies--GlaxoSmithKline, Aventis, Merck, and Wyeth--make 12 vaccines. Of the 12, seven are made by only one company and only one is made by more than two. "There are constant shortages," says Dr. Paul Offit, head of the Vaccine Education Center at Children's Hospital of Philadelphia. "With only one supplier for so many vaccines, the whole system is fragile. When even the smallest thing goes wrong, children miss their vaccinations."

The intersection between mass vaccinations and the tort system was bound to be messy. When you vaccinate enough people, someone, somewhere, is going to have a bad reaction. You could give a glass of milk to 100 million people and a few would inevitably get violently sick from it. With vaccines, there will be allergic reactions and a tiny but predictable percentage of people will suffer some kind of permanent damage or even die. Because of liability without fault and the generosity of the tort system, the result is huge damage awards.

The first instance of this came in 1955 with polio vaccinations. Cutter Laboratories, the California company that now distributes Cutter's Insect Repellent, made an early batch of vaccines, some of which had live viruses in them. Almost all the children in Idaho were administered the vaccine and several dozen contracted polio. In 1957, the parents of Anne Gottsdanker, an 8-year-old girl whose legs had become paralyzed, sued Cutter, with famed personal injury lawyer Melvin Belli representing them.

The jury found Cutter's actions were not negligent--the orders had been rushed, standards had not been clear, and safety precautions were still rudimentary at the time. But, using the new doctrine of liability without fault, the jury held Cutter accountable anyway and awarded $147,300. "That decision made Ralph Nader possible," Belli later claimed.

"It was a turning point," says Dr. Offit, whose book The Cutter Incident will be published next year. "Because of the Cutter decision, vaccines became one of the first medical products to be eliminated by lawsuits."

That this would be the outcome wasn't immediately clear. Soon after the trial, the Yale Law Journal published an article arguing that insurance against adverse reactions was the solution. The public wouldn't buy policies because it would be too complicated and expensive, but vaccine makers could. Insurance would cover the cost of bad outcomes and the manufacturers would pass these costs on to their customers. Those few who were harmed by a vaccine would be covered by those who benefited. Everything would work out. Unfortunately, this thesis failed to anticipate how high damage awards would go.


WHEN AN UNUSUAL EPIDEMIC occurred at Fort Dix, N.J., in 1976, for example, the federal government decided to vaccinate the whole country against the new "swine flu." To the astonishment of Congress, the insurance companies refused to participate. Senator Ted Kennedy charged "cupidity" and "lack of social obligation." The Congressional Budget Office predicted that with 45 million Americans inoculated, there would be 4,500 injury claims and 90 damage awards, totaling $2 million. Congress decided to provide the insurance.

As Peter Huber recounts in his book Liability, the CBO's first estimate proved uncannily accurate. A total of 4,169 damage claims were filed. However, not 90 but more than 700 suits were successful and the total bill to Congress came to over $100 million, 50 times what the CBO had predicted. The insurance companies knew their business well.

Adding to the problem are the predictable panics about vaccines that spread among parents and are abetted by trial lawyers. In 1974, a British researcher published a paper claiming that the vaccine for pertussis (whooping cough) had caused seizures in 36 children, leading to 22 cases of epilepsy or mental retardation. Subsequent studies proved the claim to be false, but in the meantime Japan canceled inoculations, resulting in 113 preventable whooping cough deaths. In the United States, 800 pertussis vaccine lawsuits asking $21 million in damages were filed over the next decade. The cost of a vaccination went from 21 cents to $11.

Every American drug company dropped pertussis vaccine except Lederle Laboratories. In 1980, Lederle lost a liability suit for the paralysis of a three-month-old infant--even though there was almost no evidence implicating the vaccine. Lederle's damages were $1.1 million, more than half its gross revenues from sale of the vaccine for that entire year.

In recent years, the most prevalent anti-vaccine rumor has held that Thimerosal, a mercury-containing preservative used in vaccines from the 1930s until just recently, is behind an "epidemic of autism." Once again, scientific studies have disproved the allegation, but hundreds of parents are filing suit, and trial lawyers continue to troll for clients.

Congress tried to stave off liability problems with the National Childhood Vaccine Injury Act in 1986. The program functions almost as an ideal "medical court," with panels of scientists, virologists, and statisticians reviewing each complaint and rewarding those that seem legitimate. Unfortunately, the program allows plaintiffs to opt out of the system. Trial lawyers continually bypass it and elect to go to trial--particularly for cases where the review looks unpromising. With Thimerosal, lawyers have argued that the law does not apply because mercury was an additive, not the actual vaccine. The result is jackpot awards and very little protection for the vaccine companies. In 1998, the FDA approved a vaccine for Lyme disease, which strikes 15,000 people a year. GlaxoSmithKline manufactured it for three years but quit when rumors began circulating that the vaccine caused arthritis.

All this has made the flu an epidemic waiting to happen. Each year flu viruses circle the globe, moving into Asia in the spring and summer and back to North America in the winter. Surface proteins change along the way so that the previous year's vaccine doesn't work against the following year's variation.

Each year in February, the Centers for Disease Control meets with the vaccine-makers--all two of them--and decides which strain of the virus to anticipate for next year. Then they both make the same vaccine. Last year the committee bet on the Panama strain, but a rogue "Fujian" strain suddenly emerged as a surprise invader. A mini-epidemic resulted and 93 children died, only two of them properly vaccinated.

With several companies competing in the field, as was once the case, somebody would have been more likely to produce a dark horse vaccine. If that rogue strain emerged, the dissenting company would hit the jackpot, and there would be ample supplies of an effective vaccine, at least for those most at risk. In the "planned economy" of the CDC, however, there is no back-up for an unexpected turn of events. This year there isn't even a front line.

Are trial lawyers ready to accept responsibility for their starring role in creating this health hazard? Don't hold your breath. "This is just the typical garbage and propaganda from the drug manufacturers," says Carlton Carl, spokesman for the Association of Trial Lawyers of America. "There's absolutely no disincentive for making vaccines. American companies don't do it for the same reason they're sending jobs overseas--because it increases their profits."

Whether doctors are quitting the profession because of an out-of-control tort system, whether malpractice premiums are the cause of health care increases--such hardy perennials of the litigation debate are still a subject of lively controversy. But with vaccines there is no argument. Trial lawyers have all but ruined the market. Yet they are still unwilling to take responsibility.

From the October 25, 2004 issue: Guess who's to blame for the flu vaccine fiasco.
by William Tucker
10/25/2004, Volume 010, Issue 07
William Tucker is a fellow at the Discovery Institute. His book on trial lawyers, Civil Lynchings, will be published next year.


© Copyright 2004, News Corporation, Weekly Standard, All Rights Reserved.

electricparadise

Oh Wow a fellow from the Discovery Institute wrote that .Talk about Slanted stuff. .Tell me Ez ,how old is the earth? Why don't you pull up one of the "fellows "essays showing without a doubt ,that we only have been around 5,000 years.Isn't that your main crux? everything revolving around your bible ,Every word etched in holy stone? Thanks man I now know what kind of person I am talking to .I feel sorry for your kind ,talk about needing to get into the 21st century! neon better check on whose side you're takin & Sizzle ,to me you are a guy in a clown suit with a mind to match.

Neon Beach

"JOHN KERRY wasted no time jumping on President George Bush about the unexpected shortage in flu vaccines this year. Why wasn't Bush paying attention? He should have done things differently. And of course Kerry had a "plan" to solve the whole mess."

If it were unexpected then how would Bush have known about it, and Kerry for that matter. Kerry should have known about it if you expect Bush to have known about it, did he just ignore it so that he could use it along with the rest of his pawn shop sales techniques? Hmmmmmm?

P.S. Can you answer that without writing a novel or should I say cut and pasting a novel?

electricparadise

It wasn't unexpected icebrain.(you really don't read all the posts do you?) The administration had THREE(like in over 1000 days) long years to fix it . They did nothing ,It's a subject that should be an issue. Shows their ineptitude in another area,not just the war.

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"IF YOUR'E PAYIN TAXES ,YOUR'E MAKIN MONEY.[ This Message was edited by: electricparadise on 2004-10-21 10:43 ]

trusno1

Bush has had over 3 years to make something, anything better. Now he wants to make promises. Why didn't he try to fix anything already? Where were all of his plans the last 3 years? Absolutely nothing is better for me or anyone I know. He has no pet project that I see except the war, banning *** marriage, and abortion. Why not let someone who is enthusiastic and wants to make a difference?

I bet if someone switched the rep. and dem. titles under the candidates a lot of republicans would vote for Kerry.

The state of the economy is partially effected by the confidence of the people buying stock. They must not be very confident, judging by my portfolio.

Before I get hammered by the economist, let me explain. As I was taught in my 3 quarters of required economy, If people feel confident they will have jobs and feel secure, they are more likely to spend it. If your future is uncertain, you squirrel it away.

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[ This Message was edited by: trusno1 on 2004-10-21 12:08 ]